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RECRUITING
NCT05928234

A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

Summary

The goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (PA-IVS) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. The main questions the study aims to answer are: • Do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with PA-IVS who have univentricular and biventricular circulation? Participants will be asked to answer a Quality of Life questionnaire. The investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).

Official title: A Longterm Follow-up and Comparison of Morbidity and Heart Health Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2024-07-15

Completion Date

2026-01

Last Updated

2025-03-30

Healthy Volunteers

No

Locations (1)

Pediatric Heart Center, Queen Silvia's Children's hospital

Gothenburg, Sweden